520 related articles for article (PubMed ID: 30030349)
1. Multiproduct Resin Reuse for Clinical and Commercial Manufacturing-Methodology and Acceptance Criteria.
Sharnez R; Doares S; Manning S; Mehta K; Mahajan E; To A; Daniels W; Glynn J; Dhamane S; Wen X; Wang Y; Gour P; Guenther C; Foley D; Hayes R; Mott A; Prabhu S; Tavalsky D; Hendershot M; Haas D; Hesslein A; Schuelke N; Tjandra H
PDA J Pharm Sci Technol; 2018; 72(6):584-598. PubMed ID: 30030349
[TBL] [Abstract][Full Text] [Related]
2. Advancing multiproduct resin reuse for development and clinical manufacturing of an antibody-based therapeutic.
Li H; Rose P; Rowicki P; Cutler C; McPhee JT; Frey C; Lemieux L; Pelette G; Ang JK; Liu R; Richardson DD
Biotechnol Prog; 2024; 40(3):e3434. PubMed ID: 38334252
[TBL] [Abstract][Full Text] [Related]
3. Evaluating multiproduct chromatography Protein A resin reuse for monoclonal antibodies in biopharmaceutical manufacturing.
Ravi N; Huerta J; Ferreira G
Biotechnol Prog; 2023; 39(3):e3333. PubMed ID: 36795072
[TBL] [Abstract][Full Text] [Related]
4. Retrospective Evaluation of Cycled Resin in Viral Clearance Studies-A Multiple Company Collaboration.
Mattila J; Curtis S; Webb-Vargas Y; Wilson E; Galperina O; Roush D; Tobler S; Stanley B; Clark M; Weaver J; Pike J; Yu D; Li X; Flicker A; Kindermann J; Schuelke N; Whitcombe R; Bennett L
PDA J Pharm Sci Technol; 2019; 73(5):470-486. PubMed ID: 31101706
[TBL] [Abstract][Full Text] [Related]
5. Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.
Barone PW; Avgerinos S; Ballard R; Brussel A; Clark P; Dowd C; Gerentes L; Hart I; Keumurian FJ; Kindermann J; Leung JC; Ly N; Mink S; Minning S; Mullberg J; Murphy M; Nöske K; Parriott S; Shum B; Wiebe ME; Springs SL
PDA J Pharm Sci Technol; 2019; 73(2):191-203. PubMed ID: 30361281
[TBL] [Abstract][Full Text] [Related]
6. Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities.
Che PL; Bailey AP; Tam CYJ; Alvarez M; Arroyo AY
PDA J Pharm Sci Technol; 2020; 74(4):377-393. PubMed ID: 32179711
[TBL] [Abstract][Full Text] [Related]
7. A safe, effective, and facility compatible cleaning in place procedure for affinity resin in large-scale monoclonal antibody purification.
Wang L; Dembecki J; Jaffe NE; O'Mara BW; Cai H; Sparks CN; Zhang J; Laino SG; Russell RJ; Wang M
J Chromatogr A; 2013 Sep; 1308():86-95. PubMed ID: 23953712
[TBL] [Abstract][Full Text] [Related]
8. An enhanced regeneration strategy to improve microbial control and prolong resin lifetime for Protein A resin in large-scale monoclonal antibody (mAb) purification.
Zhou T; Wang L; Zhang Z; Jin M
J Biotechnol; 2019 Jan; 289():118-125. PubMed ID: 30502366
[TBL] [Abstract][Full Text] [Related]
9. Exploring features in chromatographic profiles as a tool for monitoring column performance.
Ravi N; Malmquist G; Stanev V; Ferreira G
J Chromatogr A; 2023 Jun; 1698():463982. PubMed ID: 37087858
[TBL] [Abstract][Full Text] [Related]
10. The regulatory framework for preventing cross-contamination of pharmaceutical products: History and considerations for the future.
Sargent EV; Flueckiger A; Barle EL; Luo W; Molnar LR; Sandhu R; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S3-S10. PubMed ID: 27230736
[TBL] [Abstract][Full Text] [Related]
11. Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product-Hydrogen Peroxide Uptake and Impact on Protein Quality.
Hubbard A; Roedl T; Hui A; Knueppel S; Eppler K; Lehnert S; Maa YF
PDA J Pharm Sci Technol; 2018; 72(4):348-366. PubMed ID: 29545321
[TBL] [Abstract][Full Text] [Related]
12. Viral clearance studies on new and used chromatography resins: critical review of a large dataset.
Kelley BD; Jakubik J; Vicik S
Biologicals; 2008 Mar; 36(2):88-98. PubMed ID: 17997110
[TBL] [Abstract][Full Text] [Related]
13. Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities.
Garcia FA; Vandiver MW
PDA J Pharm Sci Technol; 2017; 71(3):189-205. PubMed ID: 27974629
[TBL] [Abstract][Full Text] [Related]
14. Industry perspective on the validation of column-based separation processes for the purification of proteins. Parenteral Drug Association.
J Parenter Sci Technol; 1992; 46(3):87-97. PubMed ID: 1522447
[TBL] [Abstract][Full Text] [Related]
15. Chemometrics applications in biotechnology processes: predicting column integrity and impurity clearance during reuse of chromatography resin.
Rathore AS; Mittal S; Lute S; Brorson K
Biotechnol Prog; 2012; 28(5):1308-14. PubMed ID: 22888107
[TBL] [Abstract][Full Text] [Related]
16. Maximizing the functional lifetime of Protein A resins.
Zhang J; Siva S; Caple R; Ghose S; Gronke R
Biotechnol Prog; 2017 May; 33(3):708-715. PubMed ID: 28218470
[TBL] [Abstract][Full Text] [Related]
17. Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.
Page T; Dubina H; Fillipi G; Guidat R; Patnaik S; Poechlauer P; Shering P; Guinn M; Mcdonnell P; Johnston C
J Pharm Sci; 2015 Mar; 104(3):821-31. PubMed ID: 25448273
[TBL] [Abstract][Full Text] [Related]
18. Cleaning validation of ofloxacin on pharmaceutical manufacturing equipment and validation of desired HPLC method.
Arayne MS; Sultana N; Sajid SS; Ali SS
PDA J Pharm Sci Technol; 2008; 62(5):353-61. PubMed ID: 19055231
[TBL] [Abstract][Full Text] [Related]
19. Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation.
Ma J; Kreil TR
PDA J Pharm Sci Technol; 2018; 72(5):511-515. PubMed ID: 30030359
[TBL] [Abstract][Full Text] [Related]
20. Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses.
Qiu J; Li K; Miller K; Raghani A
PDA J Pharm Sci Technol; 2015; 69(3):334-45. PubMed ID: 26048741
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
